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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04125121
Other study ID # H-18028925
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 26, 2019
Est. completion date August 13, 2021

Study information

Verified date August 2021
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to use magnetic resonance imaging to explore and compare possible de novo neuroplastic changes induced by the isolated effects of the hypnotic agents sevoflurane and propofol, respectively. In addition, to explore possible associations between neuroplastic changes and clinical and/or biochemical outcomes. It is a randomised, cross-over, single blinded clinical study. N = 30. Female:male ratio 1:1.


Description:

Background In the perioperative period, severe changes can be observed in the endocrine, immune, and nervous system. These changes are called the surgical stress response. Clinically, this can be observed as increased pain response and disturbances in the circadian rhythm, memory, cognitive and executive functions, and may lead to post-operative delirium. The post-operative cognitive dysfunction is associated with increased mortality and risk of prematurely leaving occupation. Post-operative delirium with fluctuating levels of attention and consciousness is a serious condition associated with poor outcome, including longer hospitalisation and increased early mortality. General anaesthesia may contribute to the surgical stress response. Some data indicate that general anaesthesia per se can cause alterations and disturbances in the brain such as sleep and circadian disturbances. Recent evidence suggests that anaesthetic agents may impair neurogenesis and cause memory impairment. In addition, inhalation anaesthesia may result in more cerebral disturbances compared to total intravenous anaesthesia (TIVA). In this study, we will isolate the effects of the two primary hypnotic agents used in general anaesthesia, sevoflurane and propofol, without the interactions and confounders of polypharmacy and varying levels of disease among a surgical population. Materials The study consists of two study sessions. In each study session magnetic resonance imaging (MRI) scans will be obtained before and after general anaesthesia, and in addition after one and eight days. The following imaging modalities will be employed: (i) T1-weighted 3D anatomy (T1w3D), (ii) Diffusion Tensor Imaging (DTI), (iii) resting state functional MRI (rsfMRI). The MRI scans will be supplemented with cognitive testing, sleep evaluation and blood sampling. Thus, the set-up for each volunteer will be: Session one: Day 0: MRI 1, cognitive testing, questionnaires, and blood sampling. General anaesthesia (maintenance phase with sevoflurane OR propofol according to randomisation), and post-anaesthesia care. MRI 2 and repeated cognitive testing, questionnaires, and blood sampling. Day +1: MRI 3, cognitive testing, questionnaires, and blood sampling. Day +8: MRI 4, cognitive testing, and questionnaires. Session two: Identical to session one, except the volunteer will receive the remaining type of general anaesthesia (sevoflurane or propofol, opposite to session one). Data evaluation will be conducted with assessor blinded to anaesthesia type.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 13, 2021
Est. primary completion date August 13, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Age =18 and =35. - Healthy individual. - BMI =18 kg/m2 and =30kg/m2. - Normal electrocardiogram (ECG). - Normal physical examination, including neurological examination, auscultation of the heart and lungs, and measurement of blood pressure and pulse. - American Society of Anaesthesiologists (ASA) class 1. - Mallampati I-II and simplified airway risk index (SARI) 0-2 (i.e. no indication of difficult intubation). See appendix for details. - Right-handed. - Female participants must use safe contraceptives (hormonal or mechanical, including intrauterine devices). - Speaks and understand Danish. - Provides oral and written informed consent. Exclusion Criteria: - Contraindications to MRI. - Left-handedness or ambidexterity. - History of complications to general anaesthesia, including malignant hyperthermia. - Family history of malignant hyperthermia. - Known incident of malignant hyperthermia or any unexplained complication to general anaesthesia among close relatives. - Allergy to any kind of medication or material to which the volunteer could be exposed during this study. - History of serious illness. - History of cancer, immune disease, autoimmune disease, chronic pain or neurological / psychiatric illness. - Major trauma or head trauma with any symptoms present at the time of inclusion. - Surgery less than six weeks prior to the study period. - Infection (with fever) less than two weeks prior to or during the study sessions. - Daily use of any medication (not counting contraceptives). - Consumed anti-depressants during the last 30 days before study days. - Weakly intake of >21 (for females >14) units of alcohol. - Heavy intake of caffeine (> 5 cups/day). - Smoking during the last 30 days before study days. - Substance abuse (assessed by the investigator). - Pregnancy - Reflux or dyspepsia. - Poor dental status or oral health. - Expected or suspected difficult airway. - Declines receiving information regarding accidental pathological findings during MRI scans of the brain. - Cannot cooperate to tests. - Otherwise judged unfit for participation by the investigator. Exclusion Criteria during the study: - Any of the above-mentioned exclusion criteria. - Major trauma or head trauma during the study period. - Surgery during the study period. - Infection (with fever) during the study period. - Consumption of more than 3 units of alcohol within 24 hours before each study day (intervention day or MRI scan day) - Consumed analgesics within 3 days before each study day - Consumed anti-histamines less than 48 hours before each study day - Intake of caffeine 12 h prior to each study day - Smoking

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sevoflurane-propofol
General anaesthesia with a maintenance phase of two hours duration with either sevoflurane or propofol.

Locations

Country Name City State
Denmark Department of Neuroanaesthesiology Glostrup Capital Region
Denmark Functional Imaging Unit, Department for Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Glostrup Glostrup Capital Region

Sponsors (1)

Lead Sponsor Collaborator
Signe Sloth Madsen

Country where clinical trial is conducted

Denmark, 

References & Publications (64)

American Society of Anesthesiologists Task Force on Postanesthetic Care. Practice guidelines for postanesthetic care: a report by the American Society of Anesthesiologists Task Force on Postanesthetic Care. Anesthesiology. 2002 Mar;96(3):742-52. — View Citation

Ashburner J, Friston KJ. Voxel-based morphometry--the methods. Neuroimage. 2000 Jun;11(6 Pt 1):805-21. Review. — View Citation

Bartal I, Melamed R, Greenfeld K, Atzil S, Glasner A, Domankevich V, Naor R, Beilin B, Yardeni IZ, Ben-Eliyahu S. Immune perturbations in patients along the perioperative period: alterations in cell surface markers and leukocyte subtypes before and after surgery. Brain Behav Immun. 2010 Mar;24(3):376-86. doi: 10.1016/j.bbi.2009.02.010. Epub 2009 Feb 28. — View Citation

Bigler ED, Blatter DD, Anderson CV, Johnson SC, Gale SD, Hopkins RO, Burnett B. Hippocampal volume in normal aging and traumatic brain injury. AJNR Am J Neuroradiol. 1997 Jan;18(1):11-23. — View Citation

Bonhomme V, Fiset P, Meuret P, Backman S, Plourde G, Paus T, Bushnell MC, Evans AC. Propofol anesthesia and cerebral blood flow changes elicited by vibrotactile stimulation: a positron emission tomography study. J Neurophysiol. 2001 Mar;85(3):1299-308. — View Citation

Boveroux P, Vanhaudenhuyse A, Bruno MA, Noirhomme Q, Lauwick S, Luxen A, Degueldre C, Plenevaux A, Schnakers C, Phillips C, Brichant JF, Bonhomme V, Maquet P, Greicius MD, Laureys S, Boly M. Breakdown of within- and between-network resting state functional magnetic resonance imaging connectivity during propofol-induced loss of consciousness. Anesthesiology. 2010 Nov;113(5):1038-53. doi: 10.1097/ALN.0b013e3181f697f5. — View Citation

Braz MG, Braz LG, Braz JR, Pierine DT, Correa CR, Ferreira AL, Carvalho LR, Yeum KJ, Salvadori DM. Comparison of oxidative stress in ASA physical status I patients scheduled for minimally invasive surgery under balanced or intravenous anesthesia. Minerva Anestesiol. 2013 Sep;79(9):1030-8. Epub 2013 Apr 18. — View Citation

Brooks J, Tracey I. From nociception to pain perception: imaging the spinal and supraspinal pathways. J Anat. 2005 Jul;207(1):19-33. Review. — View Citation

Brown EN, Lydic R, Schiff ND. General anesthesia, sleep, and coma. N Engl J Med. 2010 Dec 30;363(27):2638-50. doi: 10.1056/NEJMra0808281. Review. — View Citation

Campagna JA, Miller KW, Forman SA. Mechanisms of actions of inhaled anesthetics. N Engl J Med. 2003 May 22;348(21):2110-24. Review. — View Citation

Casati A, Fanelli G, Casaletti E, Colnaghi E, Cedrati V, Torri G. Clinical assessment of target-controlled infusion of propofol during monitored anesthesia care. Can J Anaesth. 1999 Mar;46(3):235-9. — View Citation

Chen MH, Liao Y, Rong PF, Hu R, Lin GX, Ouyang W. Hippocampal volume reduction in elderly patients at risk for postoperative cognitive dysfunction. J Anesth. 2013 Aug;27(4):487-92. doi: 10.1007/s00540-012-1548-6. Epub 2013 Jan 31. — View Citation

Crozier TA, Müller JE, Quittkat D, Sydow M, Wuttke W, Kettler D. Effect of anaesthesia on the cytokine responses to abdominal surgery. Br J Anaesth. 1994 Mar;72(3):280-5. — View Citation

Davis N, Lee M, Lin AY, Lynch L, Monteleone M, Falzon L, Ispahany N, Lei S. Postoperative cognitive function following general versus regional anesthesia: a systematic review. J Neurosurg Anesthesiol. 2014 Oct;26(4):369-76. doi: 10.1097/ANA.0000000000000120. Review. — View Citation

Desmond JE, Glover GH. Estimating sample size in functional MRI (fMRI) neuroimaging studies: statistical power analyses. J Neurosci Methods. 2002 Aug 30;118(2):115-28. — View Citation

Dunnet JM, Prys-Roberts C, Holland DE, Browne BL. Propofol infusion and the suppression of consciousness: dose requirements to induce loss of consciousness and to suppress response to noxious and non-noxious stimuli. Br J Anaesth. 1994 Jan;72(1):29-34. — View Citation

Editors ICoMJ. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals [Web page, recommandation]. Online: Annals of Internal Medicine / American College of Physicians.; 1978 (updated 2017) [cited 2018 20.03.2018]. Available from: http://www.icmje.org/recommendations/.

Forrest FC, Tooley MA, Saunders PR, Prys-Roberts C. Propofol infusion and the suppression of consciousness: the EEG and dose requirements. Br J Anaesth. 1994 Jan;72(1):35-41. — View Citation

Granert O, Peller M, Gaser C, Groppa S, Hallett M, Knutzen A, Deuschl G, Zeuner KE, Siebner HR. Manual activity shapes structure and function in contralateral human motor hand area. Neuroimage. 2011 Jan 1;54(1):32-41. doi: 10.1016/j.neuroimage.2010.08.013. Epub 2010 Aug 12. — View Citation

Herling SF, Dreijer B, Wrist Lam G, Thomsen T, Møller AM. Total intravenous anaesthesia versus inhalational anaesthesia for adults undergoing transabdominal robotic assisted laparoscopic surgery. Cochrane Database Syst Rev. 2017 Apr 4;4:CD011387. doi: 10.1002/14651858.CD011387.pub2. Review. — View Citation

Hofbauer RK, Fiset P, Plourde G, Backman SB, Bushnell MC. Dose-dependent effects of propofol on the central processing of thermal pain. Anesthesiology. 2004 Feb;100(2):386-94. — View Citation

Inouye SK, Marcantonio ER, Kosar CM, Tommet D, Schmitt EM, Travison TG, Saczynski JS, Ngo LH, Alsop DC, Jones RN. The short-term and long-term relationship between delirium and cognitive trajectory in older surgical patients. Alzheimers Dement. 2016 Jul;12(7):766-75. doi: 10.1016/j.jalz.2016.03.005. Epub 2016 Apr 18. — View Citation

Ishizawa Y. Mechanisms of anesthetic actions and the brain. J Anesth. 2007;21(2):187-99. Epub 2007 May 30. Review. — View Citation

Jain V, Langham MC, Wehrli FW. MRI estimation of global brain oxygen consumption rate. J Cereb Blood Flow Metab. 2010 Sep;30(9):1598-607. doi: 10.1038/jcbfm.2010.49. Epub 2010 Apr 21. Erratum in: J Cereb Blood Flow Metab. 2010 Dec;30(12):1987. J Cereb Blood Flow Metab. 2011 May;31(5):1336. — View Citation

Jevtovic-Todorovic V, Absalom AR, Blomgren K, Brambrink A, Crosby G, Culley DJ, Fiskum G, Giffard RG, Herold KF, Loepke AW, Ma D, Orser BA, Planel E, Slikker W Jr, Soriano SG, Stratmann G, Vutskits L, Xie Z, Hemmings HC Jr. Anaesthetic neurotoxicity and neuroplasticity: an expert group report and statement based on the BJA Salzburg Seminar. Br J Anaesth. 2013 Aug;111(2):143-51. doi: 10.1093/bja/aet177. Epub 2013 May 30. — View Citation

Kaisti KK, Långsjö JW, Aalto S, Oikonen V, Sipilä H, Teräs M, Hinkka S, Metsähonkala L, Scheinin H. Effects of sevoflurane, propofol, and adjunct nitrous oxide on regional cerebral blood flow, oxygen consumption, and blood volume in humans. Anesthesiology. 2003 Sep;99(3):603-13. — View Citation

Kühn S, Gleich T, Lorenz RC, Lindenberger U, Gallinat J. Playing Super Mario induces structural brain plasticity: gray matter changes resulting from training with a commercial video game. Mol Psychiatry. 2014 Feb;19(2):265-71. doi: 10.1038/mp.2013.120. Epub 2013 Oct 29. Erratum in: Mol Psychiatry. 2014 Feb;19(2):272. — View Citation

Larsen B, Seitz A, Larsen R. Recovery of cognitive function after remifentanil-propofol anesthesia: a comparison with desflurane and sevoflurane anesthesia. Anesth Analg. 2000 Jan;90(1):168-74. — View Citation

Lindqvist M, Schening A, Granstrom A, Bjorne H, Jakobsson JG. Cognitive recovery after ambulatory anaesthesia based on desflurane or propofol: a prospective randomised study. Acta Anaesthesiol Scand. 2014 Oct;58(9):1111-20. doi: 10.1111/aas.12381. Epub 2014 Aug 6. — View Citation

Lorenz IH, Kolbitsch C, Hörmann C, Schocke M, Felber S, Zschiegner F, Hinteregger M, Kremser C, Pfeiffer KP, Benzer A. Subanesthetic concentration of sevoflurane increases regional cerebral blood flow more, but regional cerebral blood volume less, than subanesthetic concentration of isoflurane in human volunteers. J Neurosurg Anesthesiol. 2001 Oct;13(4):288-95. — View Citation

Mårtensson J, Eriksson J, Bodammer NC, Lindgren M, Johansson M, Nyberg L, Lövdén M. Growth of language-related brain areas after foreign language learning. Neuroimage. 2012 Oct 15;63(1):240-4. doi: 10.1016/j.neuroimage.2012.06.043. Epub 2012 Jun 29. — View Citation

Masui K, Upton RN, Doufas AG, Coetzee JF, Kazama T, Mortier EP, Struys MM. The performance of compartmental and physiologically based recirculatory pharmacokinetic models for propofol: a comparison using bolus, continuous, and target-controlled infusion data. Anesth Analg. 2010 Aug;111(2):368-79. doi: 10.1213/ANE.0b013e3181bdcf5b. Epub 2009 Oct 27. — View Citation

Mhuircheartaigh RN, Rosenorn-Lanng D, Wise R, Jbabdi S, Rogers R, Tracey I. Cortical and subcortical connectivity changes during decreasing levels of consciousness in humans: a functional magnetic resonance imaging study using propofol. J Neurosci. 2010 Jul 7;30(27):9095-102. doi: 10.1523/JNEUROSCI.5516-09.2010. — View Citation

Miller G. Miller's Anesthesia. 2015 ed. Philadelphia: Elsevier Saunders; 2015.

Miller G. What is the biological basis of consciousness? Science. 2005 Jul 1;309(5731):79. — View Citation

Newman MF, Grocott HP, Mathew JP, White WD, Landolfo K, Reves JG, Laskowitz DT, Mark DB, Blumenthal JA; Neurologic Outcome Research Group and the Cardiothoracic Anesthesia Research Endeavors (CARE) Investigators of the Duke Heart Center. Report of the substudy assessing the impact of neurocognitive function on quality of life 5 years after cardiac surgery. Stroke. 2001 Dec 1;32(12):2874-81. — View Citation

Ní Mhuircheartaigh R, Warnaby C, Rogers R, Jbabdi S, Tracey I. Slow-wave activity saturation and thalamocortical isolation during propofol anesthesia in humans. Sci Transl Med. 2013 Oct 23;5(208):208ra148. doi: 10.1126/scitranslmed.3006007. — View Citation

Ogawa S, Lee TM, Nayak AS, Glynn P. Oxygenation-sensitive contrast in magnetic resonance image of rodent brain at high magnetic fields. Magn Reson Med. 1990 Apr;14(1):68-78. — View Citation

Peltier SJ, Kerssens C, Hamann SB, Sebel PS, Byas-Smith M, Hu X. Functional connectivity changes with concentration of sevoflurane anesthesia. Neuroreport. 2005 Feb 28;16(3):285-8. — View Citation

Pryor KO, Root JC, Mehta M, Stern E, Pan H, Veselis RA, Silbersweig DA. Effect of propofol on the medial temporal lobe emotional memory system: a functional magnetic resonance imaging study in human subjects. Br J Anaesth. 2015 Jul;115 Suppl 1:i104-i113. doi: 10.1093/bja/aev038. — View Citation

Qiu M, Ramani R, Swetye M, Rajeevan N, Constable RT. Anesthetic effects on regional CBF, BOLD, and the coupling between task-induced changes in CBF and BOLD: an fMRI study in normal human subjects. Magn Reson Med. 2008 Oct;60(4):987-96. doi: 10.1002/mrm.21759. — View Citation

Quan X, Yi J, Ye TH, Tian SY, Zou L, Yu XR, Huang YG. Propofol and memory: a study using a process dissociation procedure and functional magnetic resonance imaging. Anaesthesia. 2013 Apr;68(4):391-9. doi: 10.1111/anae.12147. — View Citation

Ramani R, Qiu M, Constable RT. Sevoflurane 0.25 MAC preferentially affects higher order association areas: a functional magnetic resonance imaging study in volunteers. Anesth Analg. 2007 Sep;105(3):648-55. — View Citation

Sagi Y, Tavor I, Hofstetter S, Tzur-Moryosef S, Blumenfeld-Katzir T, Assaf Y. Learning in the fast lane: new insights into neuroplasticity. Neuron. 2012 Mar 22;73(6):1195-203. doi: 10.1016/j.neuron.2012.01.025. Epub 2012 Mar 21. — View Citation

Sahinovic MM, Absalom AR, Struys MM. Administration and monitoring of intravenous anesthetics. Curr Opin Anaesthesiol. 2010 Dec;23(6):734-40. doi: 10.1097/ACO.0b013e3283404579. Review. — View Citation

Schilling T, Kozian A, Senturk M, Huth C, Reinhold A, Hedenstierna G, Hachenberg T. Effects of volatile and intravenous anesthesia on the alveolar and systemic inflammatory response in thoracic surgical patients. Anesthesiology. 2011 Jul;115(1):65-74. doi: 10.1097/ALN.0b013e318214b9de. — View Citation

Schlünzen L, Juul N, Hansen KV, Cold GE. Regional cerebral blood flow and glucose metabolism during propofol anaesthesia in healthy subjects studied with positron emission tomography. Acta Anaesthesiol Scand. 2012 Feb;56(2):248-55. doi: 10.1111/j.1399-6576.2011.02561.x. Epub 2011 Oct 19. — View Citation

Schneider G, Kochs EF. The search for structures and mechanisms controlling anesthesia-induced unconsciousness. Anesthesiology. 2007 Aug;107(2):195-8. — View Citation

Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25. — View Citation

Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Søreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1. Review. — View Citation

Steinmetz J, Christensen KB, Lund T, Lohse N, Rasmussen LS; ISPOCD Group. Long-term consequences of postoperative cognitive dysfunction. Anesthesiology. 2009 Mar;110(3):548-55. doi: 10.1097/ALN.0b013e318195b569. — View Citation

Steinmetz LRaJ. Anæstesi. 4 ed. Denmark: FADL's Forlag; 2014 24. marts 2014.

Strøm C, Rasmussen LS, Sieber FE. Should general anaesthesia be avoided in the elderly? Anaesthesia. 2014 Jan;69 Suppl 1:35-44. doi: 10.1111/anae.12493. Review. — View Citation

Struys MM, Sahinovic M, Lichtenbelt BJ, Vereecke HE, Absalom AR. Optimizing intravenous drug administration by applying pharmacokinetic/pharmacodynamic concepts. Br J Anaesth. 2011 Jul;107(1):38-47. doi: 10.1093/bja/aer108. Epub 2011 May 30. Review. — View Citation

Sukhotinsky I, Zalkind V, Lu J, Hopkins DA, Saper CB, Devor M. Neural pathways associated with loss of consciousness caused by intracerebral microinjection of GABA A-active anesthetics. Eur J Neurosci. 2007 Mar;25(5):1417-36. — View Citation

Sun X, Zhang H, Gao C, Zhang G, Xu L, Lv M, Chai W. Imaging the effects of propofol on human cerebral glucose metabolism using positron emission tomography. J Int Med Res. 2008 Nov-Dec;36(6):1305-10. — View Citation

Thirion B, Dodel S, Poline JB. Detection of signal synchronizations in resting-state fMRI datasets. Neuroimage. 2006 Jan 1;29(1):321-7. Epub 2005 Aug 29. — View Citation

Universities WgsubtMoHEaSatoD. The Danish Code of Conduct for Research Integrity [Code of conduct]. Online (www.ufm.dk): Danish Ministry of Higher Education and Science; 2014 [updated June 02, 2015; cited 2018 20.03.2018]. Available from: https://ufm.dk/en/publications/2014/the-danish-code-of-conduct-for-research-integrity.

van den Heuvel MP, Hulshoff Pol HE. Exploring the brain network: a review on resting-state fMRI functional connectivity. Eur Neuropsychopharmacol. 2010 Aug;20(8):519-34. doi: 10.1016/j.euroneuro.2010.03.008. Epub 2010 May 14. Review. — View Citation

Vanlersberghe C, Camu F. Propofol. Handb Exp Pharmacol. 2008;(182):227-52. doi: 10.1007/978-3-540-74806-9_11. Review. — View Citation

Veselis RA, Feshchenko VA, Reinsel RA, Dnistrian AM, Beattie B, Akhurst TJ. Thiopental and propofol affect different regions of the brain at similar pharmacologic effects. Anesth Analg. 2004 Aug;99(2):399-408, table of contents. — View Citation

Vestergaard MB, Lindberg U, Aachmann-Andersen NJ, Lisbjerg K, Christensen SJ, Rasmussen P, Olsen NV, Law I, Larsson HB, Henriksen OM. Comparison of global cerebral blood flow measured by phase-contrast mapping MRI with (15) O-H(2) O positron emission tomography. J Magn Reson Imaging. 2017 Mar;45(3):692-699. doi: 10.1002/jmri.25442. Epub 2016 Sep 13. — View Citation

Warner ME, Benenfeld SM, Warner MA, Schroeder DR, Maxson PM. Perianesthetic dental injuries: frequency, outcomes, and risk factors. Anesthesiology. 1999 May;90(5):1302-5. — View Citation

Witlox J, Eurelings LS, de Jonghe JF, Kalisvaart KJ, Eikelenboom P, van Gool WA. Delirium in elderly patients and the risk of postdischarge mortality, institutionalization, and dementia: a meta-analysis. JAMA. 2010 Jul 28;304(4):443-51. doi: 10.1001/jama.2010.1013. — View Citation

* Note: There are 64 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in T1w3D Volume and morphology of selected brain regions and anatomical structures as recorded by T1w3D anatomy MRI. 8 days
Primary Changes in DTI White matter microstructure as measured using Diffusion Tensor Imaging (DTI) 8 days
Secondary Changes in rsfMRI Differences in resting state functional MRI induced by general anaesthesia 8 days
Secondary Changes in fatigue Differences in severity and characteristics of fatigue related to general anaesthesia, as measured by Multidimensional Fatigue Inventory (MFI-20, a scale of 0-5 in each of 20 questions, with higher scores indicating more fatigue). 8 days
Secondary Cognitive performance Changes in cognitive function related to general anaesthesia, measured with a combination of Test of Attentional Performance, Paced Auditory Serial Addition Test and Conners Continuous Performance Test. 8 days
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